A 52-Week Open-Label Safety Study of PD 0332334 in Subjects With Generalized Anxiety Disorder (GAD)

Stopped early · Phase 3

Conditions studied: Generalized Anxiety Disorder

In brief

This study will assess the long-term safety and tolerability of 350 to 600 mg/day of PD 0332334 administered in split dose (twice daily) in subjects with Generalized Anxiety Disorder.

Key facts

Study ID

NCT00735267

Run by

Pfizer

People needed

468

Starts

2008-10-01

Expected to finish

2009-04-01

Last updated by the study team

2012-11-16

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must have completed all phases of one of the four preceding double-blind GAD studies.
• Female must continue to use adequate birth control methods and have a negative serum pregnancy test within 14 days prior to starting open label treatment.

You may not qualify if…

• Subjects who experienced a serious adverse event during the preceding double-blind efficacy study that was judged to be related to study medication by the investigator or the sponsor's medical monitor.
• Individuals who have an ongoing, unresolved, clinically significant medical problem that, in the judgment of the investigator or the sponsor's medical monitor, would make it unsafe for the subject to participate in the study.
• Serious suicidal risk per the clinical investigators's judgement.

Where it is running

• Pfizer Investigational Site — Litchfield Park, Arizona, United States
• Pfizer Investigational Site — Arcadia, California, United States
• Pfizer Investigational Site — Beverly Hills, California, United States
• Pfizer Investigational Site — Costa Mesa, California, United States
• Pfizer Investigational Site — Costa Mesa, California, United States
• Pfizer Investigational Site — Encino, California, United States
• Pfizer Investigational Site — Escondido, California, United States
• Pfizer Investigational Site — Murrieta, California, United States
• Pfizer Investigational Site — National City, California, United States
• Pfizer Investigational Site — Newport Beach, California, United States
• Pfizer Investigational Site — Orange, California, United States
• Pfizer Investigational Site — Pasadena, California, United States
• Pfizer Investigational Site — Redlands, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — Sherman Oaks, California, United States
• Pfizer Investigational Site — Temecula, California, United States
• Pfizer Investigational Site — Upland, California, United States
• Pfizer Investigational Site — Wildomar, California, United States
• Pfizer Investigational Site — Denver, Colorado, United States
• Pfizer Investigational Site — Hamden, Connecticut, United States
• Pfizer Investigational Site — Norwich, Connecticut, United States
• Pfizer Investigational Site — Altamonte Springs, Florida, United States
• Pfizer Investigational Site — Fort Myers, Florida, United States
• Pfizer Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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